MAUDE MDR 8267000

MDR report key
8267000
Report number
8267000
Event key
0
Event type
3
Date of event
2018-12-23
Date received
2019-01-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TEC 7VAPORIZER, ANESTHESIA, NON-HEATEDDATEX-OHMEDA, INCCADBEGH 00213* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-220

Event Narratives#

D

Patient 1

DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE PATIENT HAD JUST BEEN PLACED ON CARDIOPULMONARY BYPASS WHEN IT WAS NOTED THAT THE ARTERIAL BLOOD LOOKED DARK. THE PATIENT WAS IMMEDIATELY TAKEN OFF BYPASS. IT WAS DETERMINED BY THE PERFUSIONIST THAT THE G.E. ISOFLURANE VAPORIZER WAS INOPERABLE, AND OXYGEN WAS NOT BEING DELIVERED TO THE OXYGENATOR. THE ISOFLURANE VAPORIZER WAS NOT UTILIZED FOR THE REMAINDER OF THE CASE. THE DEVICE WAS HANDED OVER THE FACILITIES BIOENGINEER FOR TESTING. HE OBSERVED THAT THE VAPORIZER WOULD NOT STAY LOCKED ON THE HEART LUNG PUMP MOUNT. NOTABLY, FOR SAFETY REASONS THE DEVICE WILL NOT FLOW ANY GAS IF IT DOES NOT REMAIN LOCKED. THE DEVICE WAS TAKEN TO AN ANESTHESIA MACHINE AND IT LOCKED CORRECTLY AND THE OUTPUT WAS VERIFIED WITH A G.E. TECHNICIAN. ALL TEST PASSED, AND THE VAPORIZER OUTPUT GAS FLOW WAS DETERMINED TO BE WITHIN THE LIMITS SET BY G.E. NO ISSUES WERE FOUND WITH THE OPERATION OF THE DEVICE. THE MOUNTING BRACKET IN QUESTION WAS REMOVED AND REALIGNED AND THEN THE VAPORIZER WAS REATTACHED. THE DEVICE LATCH REMAINED LATCHED AND THE VAPORIZER PERFORMED AS EXPECTED ON THE HEART LUNG MOUNT. MANUFACTURER RESPONSE FOR ISOFLURANE VAPORIZER, GE ISOFLURANE VAPORIZER (PER SITE REPORTER). OUR IN HOUSE BIOMED ENGINEER CONTACTED G.E. REPRESENTATIVE AND DISCUSSED THE ISSUE AND TESTING PERFORMED.